Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy
研究概览
简要总结
Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration
详细描述
Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.
Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
排除标准
- •Unable to provide written informed consent
研究组 & 干预措施
patient with metastatic prostate cancer (mPC)
结局指标
主要结局
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy
时间窗: 3 years
Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy in patients with metastatic prostate cancer (mPC) whose tumor tissue is inadequate or unavailable for molecular testing.
次要结局
未报告次要终点